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临床试验/NCT01348464
NCT01348464已完成不适用

Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

Gachon University Gil Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年3月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Complication rate
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial

详细描述

  • primary objective
  1. complication rate
  • secondary objectives
  1. satisfaction rate
  2. pain scale difference

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 85 Years（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •age 5~85 years
  • •any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
  • •Patient performance status(PS) with greater than 80 or more on Karnofsky PS
  • •Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

排除标准

  • •Pregnant or lactating
  • •Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  • •History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
  • •Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.

结局指标

主要结局

Complication rate

时间窗: participants will be followed for the duration of hospital stay, an expected average of 24 weeks

observe complication caused by both procedures

次要结局

  • patient satisfaction(participants will be followed for the duration of hospital stay, an expected average of 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Won-Suk Lee

Assistant prof

Gachon University Gil Medical Center

研究点 (1)

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